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Cosmetic Companies May See More FDA Oversight on Labeling

Date: Apr 01, 2005


The U.S. Food and Drug Administration is threatening to step up its role in overseeing the safety of cosmetic ingredients. In a letter to the Cosmetics, Toiletry and Fragrance Association (CTFA), FDA said that it will take action against companies that fail to properly include warning statements on their products.

Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing. Failure to do so causes the product to be misbranded unless the following warning statement appears conspicuously on the principal display panel of the product's label: "Warning - The safety of this product has not been determined."

FDA has been satisfied with this regulatory framework because it has long had confidence in the industry to police itself. This task is accomplished primarily through the industry's Cosmetic Ingredient Review (CIR) Expert Panel, which assesses the safety of ingredients used in cosmetics.

FDA's letter to CTFA was in response to a petition filed by the Environmental Working Group (EWG), calling on FDA to recall or issue warning labels on an array of personal care products whose ingredients, it alleged, have not been adequately assessed for safety or may harm health.

Win-win-win

In its letter to CTFA, FDA said that it is preparing a response to EWG's petition. On the compliance issue, the Agency said it intends to "consider taking compliance action, where appropriate, regarding cosmetic products that contain ingredients that we determine have not been shown to be safe&but that are not currently labeled with the [required] warning statement."

EWG sees FDA's letter as a resounding victory, but CTFA certainly does not see it as a defeat. In a press release, the industry group indicated that it "is in complete agreement with FDA that any products with ingredients that have been determined by the CIR Expert Panel to have insufficient data for determination of safety or that fall outside the qualifications for safe use should be subject to [the warning statement] as outlined by FDA&unless there is additional data available to substantiate safety."

So, FDA has made its position clear. EWG seems pleased and so, too, does CTFA. An uncommon experience in Washington, D.C.; usually no one is happy. Thus, the only folks who have a worry are those who may be using ingredients that have not cleared the CIR Expert Panel review process. Additional work to establish the safety of those ingredients may be in order - at least to avoid use of the warning statement.

Used with permission. Copyright FOOD & DRUG PACKAGING, April, 2005.

For further information about this article, please contact George G. Misko at 202-434-4170 or by email at misko@khlaw.com.